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    58 views51 pages

    Arg-Dp Coa PDF

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    wil

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    © All Rights Reserved
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    of 51
    Ref. SOP No: AD/SOP/009 Page 1of 1 RECIPHARM PHARMASERVICES PVT. LTD., 34" KM, Tumkur Road, T — Begur, Nelamangala, Bangalore Rural - 362 123 Unit: Pharmaceutical Development Unit - CERTIFICATE OF ANALYSIS (RAW MATERIAL) RAW MATERIAL: ARG-DPG Lab Note Book No./ARDS No.:RM-0498. [ Mfg date: NA. AR No.: AD/MI-JNJ/19/0437 Date of COA: 02/0319 | Exp: date; NA Qty. Received: NA Analysis completed on: 21/06/2019 Re-test date: NA ‘Sampled by: NA. Material code: NA ‘Manufacturer: NA Sampled qty: NA RR No/SAP B. No. NA ‘Vendor B. No.: 2019010905 __| Sampled on: NA | Ref Spec. No NA LABORATORY RESULTS: SL.No. Tests ‘Specifications / Limits Results | Ay fs L (IMWww78010) White to light/pale yellow powder White powder The spectrum (infrared, Near-infrare or Raman) shall exhibit absorption The infrared spectrum exhibits > Infrared Spectrum bands of the same pattern and absorption bands of the same 7 (TMWW78013) placement as those by standard or pattem and placement as those shall be automatically identified by standard spectrum, using a validated library. Assay (as dried basis) 0 3 (IM-002790) Min 99.0% 99.7% Loss on Drying 4. | (1-2g of sample, 105 degrees C,3 hrs) Max 7.0% 6.7% L (TM7690) Residue on Ignition 0 _s Curren USPINF inonosraph 16.0-20.0% 18.6% pH (1% Aqueous solution) @ 25C 7 6. CIMWw7s014) 35-65 5.04 Heavy Metals (Pb) s 7. (TM-o06445) Max 10.0 ppm Less than 10.0 ppm Arsenic (As) 8. | (rw-ooesas) Max 2.0 ppm Less than 2.0 ppm. Conclusion: The sample coniplies / does not comply with above mentioned specification. Prepared by: [Checked by: (Approved by’ QZ ¥ aa Np . 7 ee eee ee ‘AD/FOR/10401 Ref. SOP No.: AD/SOP/009 Page Lof L RECIPHARM PHARMASERVICES PVT. LTD., 34" KM, Tumkur Road, T - Begur, Nelamangala, Bangalore Rural - 562 123 Unit: Pharmaceutical Development Unit CERTIFICATE OF ANALYSIS (RAW MATERIAL) RAW MATERIAL: ARG-DPG Lab Note Book No/ARDS No.:RM-0499 | Mfg date: NA JAR No.: AD/MI-INJ/19/0438 Date of COA: O82 HAL Exp: date: NA Qty. Received: NA. Analysis completed on: 21/06/2019 Re-test date: NA Sampled by: NA Material code: NA Manufacturer: NA ‘Sampled qty: NA RR NoJ/SAP B. No.: NA Vendor B. No.: 2019011106 Sampled on: NA Ref Spee. No.: NA LABORATORY RESULTS: Tests Specifications / Limits Results L crniw7eoto) White to lightipale yellow powder White powder { The spectrum (infrared, Near-infrare or Raman) shall exhibit absorption |The infrared spectrum exhibits > Infrared Spectrum bands of the same patter and absorption bands of the same (TMWW78013) placement as those by standard or pattern and placement as those. shall be automatically identified by standard spectrum. using a validated library Assay (as dried basis) 3 tru 002750) Min 99.0% 99.7% Loss on Drying 4. |(1-2g of sample, 105 degrees C3 hrs) Max 7.0% 6.9% L (77690) — Residue on Ignition . » 6 Current USP/NF monograph 16.0-20.0% iSove pil (1% Aqueous solution) @ 25C 6. Chtwrw7so14) 3.565 5.02 ] Heavy Metals (Pb) ] 7 arteoetis Max 10.0 ppm Less than 10.0 ppm Arsenic (A 8. Gyaves *) Max 2.0 ppm Less than 2.0 ppm Conclusion: The sample complies / does not comply with above mentioned specification weparedby CH) [Checked by: qw ‘Approved by WD 4 pest Date 2aletl i [Date sh? [Date 08 ‘ADIFORITOAOI Ref. SOP No.: AD/SOP/009 Page 1 of 1 | RECIPHARM PHARMASERVICES PVT. LTD., 34" KM, Tumkur Road, T— Begur, Nelamangala, Bangalore Rural - 362 123 Unit: Pharmaceutical Development Unit CERTIFICATE OF ANALYSIS - (RAW MATERIAL) RAW MATERIAL: ARG-DPG Lab Note Book No/ARDS No.:RM-0500 _| Mf date: NA AR No.: AD/MI-INJ/19/0439 Date of Coa: 3 [0ll9 Exp: date: NA. Qty. Received: NA. Analysis completed on: 21/06/2019 | Re-test date: NA Sampled by: NA Material code: NA Manufacturer: NA ‘Sampled qty: NA RR NoJ/SAP B. No.: NA Vendor B. No: 2019011507 | Sampled on: NA. Ref Spec. No. NA, LABORATORY RESULTS: | SI.No. | Tests Specifications / Limits Results Appearance ste to lel | 1 | aMww7s010) White to light/pale yellow powder White powder | ‘The spectrum (infrared, Near-infrared | or Raman) shall exhibit absorption ‘The infrared spectrum exhibits > Infiared Spectrum bands of the same pattern and absorption bands of the same (7™MWW78013) placement as those by standard or pattern and placement as those shall be automatically identified by standard spectrum. | using a validated library. | | Assay (as dried basis) 9 9 3 IM-002790) Min 99.0% 9.5% | | Loss on Drying 4, (1-2g of sample, 105 degrees C,3 hrs) Max 7.0% 6.6% L (1M7690) Residue on Ignit ° 5 current USP/NF monograph 16.0-20.0% 18.6% pH (1% Aqueous solution) @ 25C ® (TMWwWw78014) 3565 5.0 r Heavy Metals (Pb) 7. CIM-O06445) Max 10.0 ppm Less than 10.0 ppm 8 Gareoee) ‘Max 2.0 ppm | Less than 2.0 ppm (Conclusion: The sample coniplies / does not comply with above mentioned specification. Prepared by: (p) ~~ [Checked by: wv JApproved by NP 7 «lo Ut a\ 4 L bate oat Date eal? ate ga lai ADIFOR/I04/01 7 June 2019 REQUEST FOR CHEMICAL ANALYSIS MATERIAL: | ARG-DPG Lot# 2019010905 Lot# 2019011106 Dipotassium tot# | Lot 2019011507 INCI | Glycyrrhizate TEST Unit of METHOD SPECIFICATION measure Appearance NA TMWW78010 White to light/pale yellow powder The spectrum (infrared, Near-infrared or Raman) shall exhibit absorption bands of Infrared Spectrum NA TMWW78013 | the same pattern and placement as those by standard or shall be automatically identified using a validated library. Assay (as dried basis) % TM-002790 Min 99.0 Loss on Drying % (1-2g of sample, 105 T7690 Max 7.0 degrees C,3 hrs) . % USP Residue on Ignition Methoseoets 16.0-20.0 PH (1% aee solution) | WA TMww7e014 3.56.5 Heavy Metals (Pb ppm Tiv-006445 Max 10.0 Arsenic (As) ppm TM-006445 Max 2.0. Request Sent by- Priya Nadar- RMC/JNY. Batch No” fie NO np —tnisfee /0489 y 20/901090L po)! i wy oro gor o& 8) 0190! SO Page 1 of 2 PoIM? « sagly/943¢ polwh- INI | 0439 7 June 2019 wr 58. 4008 Dipotassium Giyoyniaate TRAVAI7BO1S Mero ATR Lor # K120387 Reference Standard MSAgO1A374 Fri Jun 08 19:18:54 2012 (GMT-05 00) Page 2 of 2 8 3a XM, Tumkur Road, T- Begun Neamangala, Bangalore Hurl 562.123, aT pared ® egy at | seers eno ces | | a [ RECIPHARM PHARMASERVICES PV PVT. ‘LTD. ARNo.: AD /1 2 | ARDS Issued by QA) Signi, : Fippensvence! — Ins lilowe 5 issued o\e§0 vwabenbe] NO Kteiiedt!— TMI FG010, Qbewuastan:— Okt powder, Peau ' Conpltes Aa 4 val we Analysed by: > | Checked by\Q} >) - ~~ . \' lowe tule ig ae: on? | Is wm hoc ts | | wa Biss ath Ref SOPNo.ADISOP/24 RECIPHARM PHARMASERVICES PVT. -LTD., | 34" KM, Tumkur Road, T~ Begur, Nelamangala, Bangalore Rural - 562 123 harmaceutical Develayment Unit ANALYTICAL RAW DATA SHEET ARDS Issue No.: pas-o498 Materi ‘Batch No. 20190109 [ARNO Adin gr Ualoue ‘a RDS Isoodly OW Sig Na oF pawesissued:p ooo gy “Tare Tryst fpeetsun - Metedi- Te 7202 Drstrumert erokle: - Noa TO Coltbiorter ave. on FTre Ao (erre fos ou lie Ng Pre cookie e! — Plosed « fample 05 He Cleonte Are c esta ond eeonned the —ppertin fr the. ome 00008 to soem, f Obeawoseen— FHe—eperktivm en sbe toe! Obeoxptier horde of He ae aster Ord plowement of those. 4 He fy ke oe a Pent: Conpleee “esig “ [ Analysed by: a | Checked by: Ny 5 viet Lowe: __ ge” : (a: ae ADFORTTT a ise Ref SOP No, ADISOP/I26 RECIPHARM /PHARMASERVICES Pv . LTD., 34" KM, Tumkur Road, T — Begur, Nelamangala, Bangalore Rural - 362 123 vaceutical Develayment Unit ,_ ANALYTICAL RAW DATA SHEET ‘Material G Product 5: ARG-DPG oo ais ~ | ARN? Ap mail TdT itlouty. ARDS Issue No.: gy.0498 [ARDS Tssued By QA) Sion eh, al Na of pagesissued: por ac} ated pain A Agoous Qolutten asayi~ Mead) —~ Prise gory PT rstsunts — debater Naw TD Calrbsotton due on Aowlutteal bolaace AdIBAL (02 ouloela Bp loa Becty. Uae Deep PP meter Procedlune!— Analysed by: ~ | Checked by: D. . | pte: alo? |b ADI: i301 : 4 CO Bene om€ ogton lt | | RECIPI PHARMASERVICES PVT.LTD. | 34" KM, Tumkur Road, T— Begur, Nelamangala, Bangalore Rural - 562 123 Unit: Pharmaceutical Devela»ment Unit Ref, SOP No. ADISOP/I24 ANALYTICAL RAW DATA SHEET Material o Product 6: ARG-DPG SCS | 2019010905. ARNO: rae) Batch No. : F019 10432. | ARDS Issue NO. Ry.0098 ~__| ARDS Issued by QA) ENE stout Na oF pagesissued:y User 1D Default Buffer Group :CUSTOM(AUTO) Standardized Values :1.690,4.010,6.860,12.45 Last sta.Date 314 Jun 2019 / 9:27:46 Signatix Ye i pine iO eerie arn Temp. mv Slope pH ) [cit 96-2019 14.9 2019 / 2:47:27 pment 23.2.¢(RTC) 305.4 SBS%P53mv 5.02 14.06.2019 14 dun 2019 / 2:45:31 PHVA 23.2C(ATC) 108.7 93.56 /55.3mv 5.05 Noetefedtnog acon Sample ord added 9.91909 wyobeh HEA Hye @ 6. 1002 ge Sample ond added 9 ae y Wootten 1 Qeewoived ead cRerked Ko P Tafel © 2 S05 Trt @ = 6.08 ay -Ahoge = © o8¢ Qe(feranse:- 0 U Obswwrdters — Sar C Crcigproston 2 ) - 26-65 SSS &p ‘ 6s) Deous Ie Compltes, Analysed by: Date: ADHORIIIDT pone. eras (3 cat | Page, Let -RECIPHARM PHARMASERVICES PVT. LTD. LTD., 34" KM, Tamar Road, — ‘Begur, Nelamangala, Bangalore Rural - ‘302 123 - - harmaceutical Develament Unit ANALYTICAL RAW DATA SHEET “Material 0 Product 0: ARG. Batch No. : 2019010905 [ ARNo. Gp pir ARDS Issue No.: Ry.0498 =] [ ARDS, Si Ba N Fr ‘at abated haste) * a Me toad TH 0003 90, Dns turmedt— oletetie — Nome. =D Colnbardton dve on rely teal dy ork [od oKfoe NF rq ese POPES Ry uv Adfuv/or MBSO6NNF Chomsoal defatier— - Nowe muke habe Ao. TA vee very Cxonal Hagan 1 (B24 le /o6teo otlute -aleohol?- Added Prapovintton ¢ to Oo LD -MD 20D aad i Pbkonot vol uynabte te i AlePolved aso’ of fro Volume woh hpegton Procedute! — Weighing ——- Analysed by: - “7 Checked by: | \' Date: a Date: _ el” ADORATSST - S327... . - frsasme(Geatets | _Ret SOP No. ADISOP/I26 - "RECIPHARM PHARMASERVICES PVT. LTD., LTD., 34° KM, Tumkur ‘Road, T—Begur, Nelamangals, Bangalore Rural - 562 123, raceutical Develayment Unit Cr ANALYTICAL Material o Product Gi ARG-DPG. | Batch No.: 2019010905 | ARNo. Ab ata 5 Tiley Bus ARDS Issue No.!pyy.0498 _| ARDS Issued by QA) Sign! [Xe of pagesissued: sia fed 02.1 Sauple PR aso mw Mouth fork, aterolvea! dtd #2 yalume wth dituted oleate! — Prpltfcd 10 au He Polutfen abo OK Oval velumerete flock ord delutod Volume wat hile, ele oho! nd tect) he AAO EALLLAA, Abeosphien peak Moses the reuerorg st fase am and ATT Am, The montnun orb sonp Hen Pooks = Bue! W o* a "othe a a Checked by: 7 | Analysed by: ® ee | Dae wor Dae: | oo Gxinued to yee oy, te Ref. SOP No.AD'SOP/I24 Page Loft -RECIPHARM PHARMASERVICES PVT. LID. — 34" KM, Tumkur Road, T — Begur, Nelamangala, Bangalore Rural - 362 123 Develyment Unit ANALYTICAL RAW DATA SHEET 7 Bateh No. : 2919010905 |_ARDS Issue No. y.9498 - ignl, 7 qn do a a PEL ulauld - Loe on TT Rledhoch: - TR 3640. Tastiumend- deporte! — nowe LD Coultieoron Jue er. Ly Heed AnulyHrel balance A0/RALIOS _ M9 Owen Adloven/og aslion pi dune? un! © “ he crdune! - wa---—= Yeighing ~ 18, Jun 2619 ei ghBridge Terminal SNRt 82 Balance ID AD/BAL, Euphe Lob i Fuply 0p bottle. 4s Lop bol let £0. 3 roopwile reuple. 5 Qe san BSis 10:08 in 2819 ‘ 5 oe yo Fi Ne 1D. ature ab ature yer ele wef 7 - — - Bie 18. Jun lei ghBridge Terminal SNR: Balance ID ance 1D Loo ble + eetdve. | 4 LOO bottler sechdoed?, 931 Gy i8sun 19 bBo 2 | Analysed by: ee . cate | Date: . = _ - Co 1 ADIFURTISI, #322 ser sons ansonmn bres om toe 8 | | mo age bath | _ RECIPHARM PHARMASERVICES PVT. LTD., 34" KM, Tumkur Road, T — Begur, Nelamangal, Bangalore Rural - 562 123 Unit: Pharmaceutical Develepm - ~KNALYTICAL RAW Dat. Material o Product 3: ARG-DPG | Batch No. 2019010905 | ARNo.: INT (19/04 | ARDSTSSNEN. 0998 || ARDS Issued by QA) Siew By. sal moo Na of pagesissueds passat og aol Oe! tool @ 2. 0026 fopal @ 2.0008 ee Garple. 9K B prcienvely — Leeted vl“ cohen, i bottles and Lob ‘Sedgfes! mR howe Aten 2 houge taken He eunpie oad Caoled Ya nt HOE ReLiLe epee WR edt? Sestontoe end foukor te. Posmunte! % top - _Panpte ARI GA ~ Pettdve we fout— Gavpie WOR ORS— X60, Sto. 0036 —~ eg 2.0036 ~ k1o0 = 6 6430 Thfoo@® . 2.0043- | 8695 oo Kee 2 -C0uz 7% Deferences Og 7 = 6.1056 Avessae Ga C. ese Mox3-0 7.) Obsewadtta = 6.2 Recut Compltes - Analysed by: g D) Date (lo buy AbaORITBOT site f copy, i pind OD | sesncnss La om lestts || — RECIPHARM. PHARMASERVICES PVT. LTD., ——7 34" KM, Tumkur Road, T —Begur, Nelamangnia, Bangalore Rural - 362 123 _ - Unit: Pharmaceutical Development Unit __ ANALYTICAL RAW DATA SHEET > NT T4]ou 7s [ ARDS Issued by QA) Sig GSH alent Naot Pa Pagesissuct:og dhe Y t A pare 7 06 ga Foousster- Dipotaseto m ag tyegoniriese Quiet 7 = 7) x 26000 «CRD = joo W) ‘ A= moxPmu obs osporen peaks nearing fee rooweteegis sg nm ond OSF AM Re % Gold 0% Clon- % Lon) ye Compe. wourght Corleuvtedton: — : G 4 xasooo yftec ia 4 06-3) en 8 = 99. 6 8ue Obsemmustern = 99 a % Cpegpreanrents 9, Pest - Compltce Analysed bys Apronsar a | pat CORY! Sian snd Band & G0 f ve sesrss son Ces ontS calis 5 sus t _ RECIPHARM PHARMASERVICES PVT. LTD., 34" KM, Tumkur Road, T - Begur, Nelamangala, Bangalore Rural - $62 123 | Lo ___Unit: Pharmaceutical Develayment Unit [ ANALYTICAL RAW DATA SHEET | Material a Product a°ARG-DPG — i Batch No.: 2919010905. l AR No. = 00 frit - agaa /14/10 ge [ARDSssueNogoaos | ARDS Iosued by QA) Sign? bai Les Sdue oA Toatton! — Fetes Qgotadt UC PAP, ee chopheh

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